{
  "type": "problem",
  "slug": "needs-ce-marking",
  "lang": "en",
  "url": "https://www.conphora.com/solutions/problem/needs-ce-marking/",
  "markdown": "https://www.conphora.com/solutions/problem/needs-ce-marking.md",
  "title": "We do not know if our product needs CE marking",
  "description": "When CE marking is required: only where an EU harmonisation act provides for it, how to test scope under LVD, EMC, RED and toys, and what to do if not.",
  "answer": "CE marking is required only where an EU harmonisation act provides for it, and Regulation (EC) No 765/2008 forbids it on any other product. Check the scope article of each candidate act, such as the Low Voltage, EMC and Radio Equipment Directives or the Toy Safety Directive. If one applies, assess conformity, draw up the declaration and affix CE. If none applies, the GPSR governs the safety of consumer products.",
  "theme": {
    "id": "placing-on-market",
    "label": "Placing a product on the market"
  },
  "roles": [
    {
      "id": "manufacturer",
      "label": "Manufacturer"
    },
    {
      "id": "importer",
      "label": "Importer"
    }
  ],
  "regulations": [
    "LVD",
    "EMC",
    "RED",
    "TSD",
    "GPSR"
  ],
  "path": [
    "free-compliance-check",
    "regulation-library"
  ],
  "trigger": "A new product is designed or sourced and a buyer, a supplier or a marketplace asks whether it should carry the CE mark",
  "keep": null,
  "why": [
    {
      "text": "The CE marking is not a quality label and not a general safety sign. Regulation (EC) No 765/2008 sets its general principles: it is affixed only by the manufacturer or its authorised representative, only to products for which specific harmonisation legislation provides for its affixing, and not to any other product (Article 30(1) and (2)). By affixing it, the manufacturer takes responsibility for conformity with all applicable requirements of the acts that provide for it (Article 30(3)). Member States act against improper use and provide penalties, which may include criminal sanctions for serious infringements (Article 30(6)).",
      "sources": [
        1
      ]
    },
    {
      "text": "So the question is never \"does the product need CE\" in the abstract, but \"does an act that provides for CE cover this product\". Each act answers that in its scope article. The Low Voltage Directive covers electrical equipment designed for use with a voltage rating of 50 to 1 000 V AC or 75 to 1 500 V DC, except the equipment and phenomena in Annex II, such as electricity meters, plugs and socket outlets for domestic use and electric fence controllers (Directive 2014/35/EU Article 1 and Annex II). The EMC Directive covers equipment, meaning apparatus and fixed installations, where apparatus is a finished appliance intended for the end user and liable to generate electromagnetic disturbance or to be affected by it (Directive 2014/30/EU Articles 2(1) and 3(1)), except the equipment listed in Article 2(2), such as equipment covered by the radio directive.",
      "sources": [
        2,
        3
      ]
    },
    {
      "text": "Radio and toys follow the same logic. Radio equipment is an electrical or electronic product that intentionally emits or receives radio waves for radio communication or radiodetermination (Directive 2014/53/EU Article 2(1)(1)); equipment within that directive is not subject to the Low Voltage Directive, except for the safety objectives applied through its Article 3(1)(a) (Article 1(4)). The Toy Safety Directive covers products designed or intended, exclusively or not, for use in play by children under 14, except the products listed in its Annex I and the toys listed in Article 2(2), such as playground equipment for public use and toy steam engines (Directive 2009/48/EC Article 2). From 1 August 2030 the Toy Safety Regulation (EU) 2025/2509 replaces the directive (Articles 56 and 59 of that regulation). These acts are examples: other Union acts, not covered on this page, also provide for CE marking.",
      "sources": [
        4,
        5,
        8
      ]
    },
    {
      "text": "Where an act applies, it sets the route to the CE marking. Under the Low Voltage Directive, the manufacturer draws up the technical documentation and carries out the conformity assessment of Annex III; once compliance is demonstrated, it draws up an EU declaration of conformity and affixes the CE marking (Article 6(2)), keeping both for 10 years (Article 6(3)). The marking is affixed visibly, legibly and indelibly, before the product is placed on the market (Article 17). Distributors verify that it is there (Article 9(2)), and for products under the listed harmonisation acts the EU economic operator verifies that the declaration and technical documentation have been drawn up (Regulation (EU) 2019/1020 Article 4(3)(a)).",
      "sources": [
        2,
        6
      ]
    },
    {
      "text": "Where no such act applies, the product is not unregulated. The General Product Safety Regulation applies to consumer products insofar as no specific Union provisions with the same objective regulate their safety (Article 2(1)), economic operators may place only safe products on the market (Article 5), and the manufacturer carries out an internal risk analysis and draws up technical documentation before placing the product on the market (Article 9(2)).",
      "sources": [
        7
      ]
    }
  ],
  "steps": [
    {
      "name": "Describe the product in scope terms",
      "text": "Write down the facts the scope articles turn on: supply voltage and current type, whether it contains electronics, whether it intentionally emits or receives radio waves, whether it is designed or intended for play by children under 14, and who will use it. These facts decide the answer more than the product name does.",
      "item": "free-compliance-check"
    },
    {
      "name": "Test each candidate act against its scope article",
      "text": "Low Voltage: electrical equipment rated 50 to 1 000 V AC or 75 to 1 500 V DC, minus the Annex II list. EMC: finished apparatus liable to generate or be affected by electromagnetic disturbance, minus the Article 2(2) exclusions, among them radio equipment. Radio Equipment: products that intentionally emit or receive radio waves; they leave the Low Voltage and EMC Directives but meet their objectives through the radio directive. Toys: products for play by children under 14, minus Annex I and Article 2(2). These four are examples; other acts also provide for CE.",
      "item": "regulation-library"
    },
    {
      "name": "If an act applies, complete its procedure before the CE",
      "text": "Draw up the technical documentation, carry out the conformity assessment the act prescribes, then draw up the EU declaration of conformity and affix the CE marking. Under the Low Voltage Directive the CE marking is affixed visibly, legibly and indelibly before the product is placed on the market."
    },
    {
      "name": "If no act applies, do not affix CE",
      "text": "The CE marking may only be affixed to products for which a harmonisation act provides for it. A consumer product with no such act still has to be safe: the General Product Safety Regulation requires an internal risk analysis, technical documentation and the identification and contact details on the product."
    },
    {
      "name": "As an importer, verify rather than assume",
      "text": "For products under the listed harmonisation acts, the EU economic operator verifies that the declaration of conformity and the technical documentation have been drawn up and keeps the declaration available. Ask the manufacturer which acts it applied and why, and compare the answer with your own scope check."
    }
  ],
  "documents": [
    {
      "name": "A short scope note per product: the acts considered, the scope test and the conclusion",
      "from": "The manufacturer, kept with the technical documentation",
      "ground": "Supporting record for Regulation (EC) No 765/2008 Article 30(2) and (3) and GPSR Article 9(2); the text does not require a separate scope note"
    },
    {
      "name": "The EU declaration of conformity and technical documentation where an act applies",
      "from": "The manufacturer",
      "ground": "Directive 2014/35/EU Article 6(2) and (3); Regulation (EU) 2019/1020 Article 4(3)(a)"
    }
  ],
  "risks": [
    {
      "title": "CE on the wrong product is itself an infringement",
      "text": "The CE marking may be affixed only to products for which specific harmonisation legislation provides for it; Member States take action against improper use and provide penalties, which may include criminal sanctions for serious infringements (Regulation (EC) No 765/2008 Article 30(2) and (6)).",
      "source": 1
    },
    {
      "title": "Missing CE stops the distribution chain",
      "text": "Before making electrical equipment available, distributors verify that it bears the CE marking and is accompanied by the required documents (Directive 2014/35/EU Article 9(2)); the same check applies to toys (Directive 2009/48/EC Article 7(2)).",
      "source": 2
    },
    {
      "title": "Authorities require correction or withdrawal",
      "text": "Where a product does not conform to applicable harmonisation legislation, authorities require corrective action, which can include rectifying formal non-compliance, and ensure withdrawal or a sales ban if it is not taken (Regulation (EU) 2019/1020 Article 16(1)–(3) and (5)).",
      "source": 6
    }
  ],
  "faq": [
    {
      "q": "Can we put CE on our product to make it look compliant?",
      "a": "No. CE may be affixed only to products for which specific harmonisation legislation provides for it, and not to any other product (Regulation (EC) No 765/2008 Article 30(2))."
    },
    {
      "q": "Our product runs on a 12 V adapter. Does the Low Voltage Directive apply?",
      "a": "The directive applies to electrical equipment designed for use with a voltage rating of 50 to 1 000 V AC or 75 to 1 500 V DC (Directive 2014/35/EU Article 1). A 12 V product is outside that range. A separate adapter that plugs into the mains is designed for mains voltage; assessing the adapter and the product separately is a reading of Article 1, not a rule stated in it. The EMC Directive and, for consumer products, the GPSR can still apply to the 12 V product."
    },
    {
      "q": "Our product has Bluetooth. Is it LVD or RED?",
      "a": "Radio equipment within the Radio Equipment Directive is not subject to the Low Voltage Directive, except that its safety objectives apply through Article 3(1)(a) of the radio directive (Directive 2014/53/EU Article 1(4)). It is also outside the EMC Directive (Directive 2014/30/EU Article 2(2)(a), which names the former Directive 1999/5/EC, read as the radio directive under its Article 50); electromagnetic compatibility is required by Article 3(1)(b) of the radio directive."
    },
    {
      "q": "Who affixes the CE marking?",
      "a": "Only the manufacturer or its authorised representative. By affixing it, the manufacturer takes responsibility for conformity with all applicable requirements of the acts that provide for it (Regulation (EC) No 765/2008 Article 30(1) and (3))."
    },
    {
      "q": "If no CE act applies, are we free of rules?",
      "a": "No. The General Product Safety Regulation applies to consumer products insofar as no specific Union rules with the same objective regulate their safety (GPSR Article 2(1)), and only safe products may be placed on the market (Article 5)."
    }
  ],
  "sources": [
    {
      "title": "Regulation (EC) No 765/2008 setting out the requirements for accreditation and market surveillance (consolidated text of 16 July 2021)",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02008R0765-20210716",
      "accessed": "2026-10-04"
    },
    {
      "title": "Directive 2014/35/EU on electrical equipment designed for use within certain voltage limits (consolidated text of 30 May 2026)",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02014L0035-20260530",
      "accessed": "2026-10-04"
    },
    {
      "title": "Directive 2014/30/EU on electromagnetic compatibility (consolidated text of 30 May 2026)",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02014L0030-20260530",
      "accessed": "2026-10-04"
    },
    {
      "title": "Directive 2014/53/EU on radio equipment (consolidated text of 30 May 2026)",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02014L0053-20260530",
      "accessed": "2026-10-04"
    },
    {
      "title": "Directive 2009/48/EC on the safety of toys (consolidated text of 29 August 2026)",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009L0048-20260829",
      "accessed": "2026-10-04"
    },
    {
      "title": "Regulation (EU) 2019/1020 on market surveillance and compliance of products (consolidated text of 12 August 2026)",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02019R1020-20260812",
      "accessed": "2026-10-04"
    },
    {
      "title": "Regulation (EU) 2023/988 on general product safety (consolidated text of 29 May 2026)",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02023R0988-20260529",
      "accessed": "2026-10-04"
    },
    {
      "title": "Regulation (EU) 2025/2509 on the safety of toys",
      "publisher": "EUR-Lex",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025R2509",
      "accessed": "2026-10-04"
    }
  ],
  "related": [
    "ce-mark-wrong",
    "which-regulations-apply",
    "power-adapter-imported",
    "charger-common-port",
    "first-product-launch"
  ],
  "reviewer": "Conphora compliance team",
  "reviewedAt": "2026-10-04",
  "notice": "General information, not legal advice."
}